Determination of the dissolution of pregabalin capsule by HPLC

OBJECTIVE To develop a method for determination of dissolution of pregabalin capsule by HPLC.METHODS The hydrochloric acid solution(9→1000) was act as dissolution medium.A Lichrospher-C18 column was used with mobile phase of methanol-acetonitrile-20mM phosphate buffer(pH7.0)(350∶100∶550),the flow rate was 1.0 mL·min-1 and detection wavelength was 210nm,external standard method was used for quantitative analysis.RESULTS The calibration curve of pregabalin concentration and peak area was linear in the range of 150.6～351.4μg·mL-1,the average recovery was 97.0%(n=9).The average cumulation dissolution rate of pregabalin capsule at 30 min was 95.1%.CONCLUSION The dissolution of pregabalin capsule is good,the determination method has high specificity and accuracy and could be used for quality control of pregabalin capsule.